Japan gives emergency approval to Shionogi’s oral COVID-19 drug

Ella Castle

Japan’s health ministry on Tuesday granted fast-track approval to Shionogi & Co.’s COVID-19 tablet Xocova, making it the country’s first domestically produced oral medicine against the coronavirus. The medicine for COVID-19 patients aged 12 or older with mild symptoms also became the first drug authorized under the new emergency approval […]

Japan’s health ministry on Tuesday granted fast-track approval to Shionogi & Co.’s COVID-19 tablet Xocova, making it the country’s first domestically produced oral medicine against the coronavirus.

The medicine for COVID-19 patients aged 12 or older with mild symptoms also became the first drug authorized under the new emergency approval scheme established in May.

Shionogi & Co.’s oral COVID-19 drug Xocova. (Photo courtesy of Shionogi & Co.)(Kyodo)

“As soon as the distribution system is ready, we plan to start delivering the drug so it can be used for treatment from early December,” Health, Labor and Welfare Minister Katsunobu Kato told a press conference after a panel of experts backed the treatment by a majority.

The decision on the treatment requiring seven Xocova tablets over five days comes as Japan has been experiencing a rebound in its number of daily COVID-19 cases, with prefectural governments across the country reporting a total of 124,004 on Tuesday, up about 18,000 from a week earlier. The number of deaths totaled 178.

Tokyo reported 12,758 infections, while Hokkaido and the northeastern Japan prefectures of Iwate and Yamagata logged new record highs.

The Japanese government has eased restrictions on people’s activities, including removing its cap on daily foreign arrivals and starting a subsidy program for residents to boost domestic tourism.

The Pharmaceuticals and Medical Devices Agency, which conducted the preliminary review, acknowledged in a report that it had “obtained sufficient information to presume the drug is effective” from final phase clinical trial results submitted by Shionogi.

A health ministry panel in July had postponed granting an emergency approval for the drug after the Japanese pharmaceutical firm was unable to demonstrate its efficacy in its mid-phase clinical trials.

Although the trials showed effectiveness in reducing coronavirus in the body, there were no substantial differences in alleviating a total of 12 symptoms such as headaches and nausea between those given the drug versus the placebo.

But an analysis of five symptoms characteristic of the Omicron strain — runny nose, sore throat, cough, fever and fatigue — in the final phase of the trials showed the drug shortened symptoms from eight days to seven days.

The final phase, conducted in Japan, South Korea and Vietnam, administered the drug once daily for five days to patients with mild or moderate COVID-19 symptoms, irrespective of their risk of developing severe symptoms or vaccination status.

The Japanese government has agreed to purchase doses sufficient for one million people once the use of the drug, the third oral treatment in the country, is greenlit.

Japan had already authorized the use of two oral COVID-19 drugs developed by U.S. pharmaceutical firms Pfizer Inc. and Merck & Co., respectively, for patients with mild symptoms.

“We are proud to reach this landmark step which marks the start of our real contribution to people’s recovery from (COVID-19),” Shionogi said in a statement.


Related coverage:

Japan has entered 8th wave of COVID-19 pandemic, medical body says

More deaths, elderly cases fuel concern about Japan’s new COVID wave

Japan postpones decision to approve 1st domestic oral COVID-19 drug


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